Reaction mass of 2-octyldodecyl 2-hydroxypropanoate, 2-Octyldodecan-1-ol and 2-octyldodecyl 2-[(2-hydroxypropanoyl)oxy]propanoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30. October - 2 November 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

The procedure followed is a modification of that described by J. H. Draize. This protocol was designed to satisfy the requirements of the Japanese Ministry of Health and Welfare.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Cosmol 13

IUPAC Name:

Cosmol 13

Details on test material:

The test substance was applied as received.

Specific details on test material used for the study:

Lot No. 1-8-A

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: 3 month
- Weight at study initiation: 2 kg
- Housing: stainless stell cages
- Diet (e.g. ad libitum): 100 g/d
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C - 24°C
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: To:

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved and partially abraded

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 ml of the test substance, as received, was applied

Duration of treatment / exposure:

24 h

Observation period:

72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 square cm
- Type of wrap if used: square gauze pad, fixed in place with Kendall Webril pad and three inch cloth tabe, impermeable occlusive plastic wrapping

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water and paper towels, if remaining substance is present,
- Time after start of exposure: 24 h

SCORING SYSTEM:

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not specified

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

not specified

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Score:

1.33

Max. score:

4

Reversibility:

not specified

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

48 h

Score:

0.33

Max. score:

4

Reversibility:

not specified

Results 5

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

1.33

Max. score:

4

Reversibility:

not specified

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Score:

0.67

Max. score:

4

Reversibility:

not specified

Irritant / corrosive response data:

Rabbit number Skin 24 hours 48 hours 72 hours
/sex ER ED ER ED ER ED
1 / F intact 2 1 1 0 1 0 S
abraded 2 1 1 0 1 0 S
2 / M intact 2 1 1 0 1 0 S
abraded 2 1 1 0 1 0 S
3 / M intact 2 1 2 1 2 2
abraded 2 1 2 1 2 2
ER = Erythema ED = Edema Scores S = Scaling

Other effects:

scaling on rabbit skin of 2 animals

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: not specified

Conclusions:

Under the conditions of this test, this test article elicited very slight to well defined erythema and very slight to slight edema and scaling on rabbit skin.